Introduction
Methods and materials
Review question
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P _ Children and adolescents (under 18).
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I _ Different interventions used alone or in combination with local anesthesia.
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C _ Among different interventions.
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O _ Reducing pain and discomfort related to rubber dam clamp.
Eligibility criteria
Search strategy, data collection, and risk of bias assessment
Database | Search string |
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MEDLINE (via PubMed) | “(Clamp OR "Rubber Dams"[Mesh] OR (rubber dam*)) AND (gingiva* OR gum OR "Gingiva"[Mesh] OR dent* OR teeth OR tooth OR "Tooth"[Mesh]) AND (pain OR "Pain"[Mesh] OR discomfort)” |
Other databases (EMBASE, Web of Science (All databases), SCOPUS, Cochrane Central register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, and ProQuest Dissertations & Theses Database Global) | (Clamp OR (rubber dam*)) AND (gingiva* OR gum OR dent* OR teeth OR tooth) AND (pain OR discomfort |
Data analysis
Results
Study selection and data retrieval
Authors, year of publication, country | Trial design | Age (years), gender (%) | Initial child behaviour/ Previous dental experiences | Intended dental treatment(s) | Interventions for pain/discomfort reduction | Tooth type /eruption status | Assessment tool(s) for Pain/discomfort | Effectiveness of interventions during rubber dam application/clamp placement | |
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Category (#n) | Descriptions | ||||||||
Crossover | 4–12 (8.34 ± 2.1) M:72%- F:28% | Fully cooperative (Frankl grade 4) during examination /Y: 93%, N: 7% | Routine pediatric dental treatment that included IANB and rubber dam placement | LA + VR distraction (n = 29 C) | VR goggles: Oculus Go VR goggles from Facebook Technologies (Oculus Go virtual reality goggles, Meta Quest, Facebook Technologies, LLC) Content: 2 cartoon series, one children’s show (average screening time: ~ 30 min) | NM/NM | 1-Wong-Baker FACES Pain Rating Scale (self-report) (0–10) 2- MBPS (facial expression, crying, and movement) (0–9) | The use of VR glasses resulted in lower mean scores of the Wong-Baker FACES Pain Rating Scale (P = 0.005) and MBPS parameters (Face (P = 0.005), Cry (P = 0.029), and Movement (P = 0.028)). The order of using VR goggles had no significant effects on pain levels (P > 0.05) | |
LA (n = 29 C) | Treatment was performed without the VR goggles | ||||||||
Crossover | 5–8 (6.2 ± 1.3) M: %55.6-F: %44.4 | Frankl scale: -Abstract: II (%42.8) and III (%57.2)/ -Methods section:I (%42.8) and II (%57.2)/no previous dental experience | Cavity preparation, pulpotomy/SSC | LA + AV distraction (n = 36 T/C) | Video Eyeglasses/Earphones System: Virtual Private Theater Video Glasses (Chinavision®; Kowloon, Hong Kong, China), with earphones | Upper or lower primary molars/NM | FLACC scale (0–10) | Pain perception following rubber dam placement was NSS (P = 0.7) | |
LA + BM (n = 36 T/C) | Other (non-aversive) behavioural techniques, such as the “tell-show-do” method and continuous verbal communication | ||||||||
Parallel | 5–9 M: 42.9%-F: 57.1% | Positive or definitely positive according to the Frankl behavior classification scale/NM | Pulpotomy | LA-IANB (n = 31 C) | Traditional IANB using traditional syringe and lidocaine HCl 2% with epinephrine (1:100,000) | Primary mandibular second molars/NM | SEM scale (3–12) | Difference between three techniques for clamp placement was NSS (P = 0.635). Moreover, the correlation between age and anesthesia effectiveness for clamp placement was weak (r = 0.145) | |
CCLAD-IANB (n = 30 C) | IANB using CCLAD performed with Single Tooth Anesthesia System (manufactured by Milestone Scientific) and lidocaine HCl 2% with epinephrine (1:100,000) | ||||||||
CCLAD-ILA (n = 30 C) | ILA injection using CCLAD performed with Single Tooth Anesthesia System (manufactured by Milestone Scientific) and lidocaine HCl 2% with epinephrine (1:100,000) | ||||||||
Crossover | 5–8 (6.9 ± 0.9) M: 38%- F: 62% | Frankl scale 3 or 4 (positive behavior patients)/Y: 62% (with LA: 21%, without LA: 41%), N: 38% | Restorative treatment (amalgam and composite fillings, SSCs, pulpotomy, pulpectomy, and Ext) | LA + AV distraction (n = 42 C) | AV eyeglasses composed of headmounted display (video glasses cool vision 3—Shenzhen Longway Vision Technology Co. Ltd, Shenzhen, China) and in-ear headphones | Maxillary or mandibular molars /NM | 1- FPS-R (0–10) 2- FLACC scale (0–10) | FLACC scores for the effect of wearing AV eyeglasses in both groups (the sequence of using AV eyeglasses was different) were NSS (P = 0.476). This was also true for period effect (P = 0.351) and carry-over effect (P = 0.806) | |
LA + BM (n = 42 C) | tell-show-do, positive reinforcement, and conventional distraction (deep breath or breath counting) | ||||||||
Parallel | 6–8 (7.2 ± 0.6) M: 50%- F: 50% | Frankl behavior rating scale 3 and 4 (positive and definitively positive)/ NM | Pulpotomy | LA- Articaine (n = 81 C/T) | injection of 1 mL 4% articaine HCl with 1:100,000 epinephrine (Ultracaine DS®, Aventis, Istanbul, Turkey) with a five-min waiting time | Maxillary or mandibular primary molars/NM | FHTLC-pain-related behaviors (Facial expression, eye squeezing, hand movements, torso movements, leg movements, crying) | The differences between the two LA agents were NSS, irrespective of administration technique (P > 0.05) | |
LA- Prilocaine (n = 81 C/T) | Injection of 1 mL of 3% prilocaine HCl with 1.08 μg felypressin (Citanest® Octapressin, AstraZeneca, Istanbul, Turkey) with a 5-min waiting time | ||||||||
Split-mouth | 6–9, M: 43%- F: 57% | Children whose behaviour interfered with an assessment of discomfort or pain were excluded/ NM | Restoration (Class III, IV, and V), pulpotomy, Ext | LA-infiltration (n = 36 C/T) | Needle was advanced in the mucobuccal fold towards the apex of the teeth. 1.2 mL of 2% lidocaine HCl with epinephrine 1:80,000 (Lignospan® Septodont; Mazamet Cedex, France) was used with a 5-min waiting period | Mandibular primary canines/ NM | Assessments were based on sounds, motor, and ocular changes indicating pain (hand and body tension, eye movement, verbal complaints, tears) | The differences in pain between two anaesthetic techniques during rubber dam placement for restorative treatments (P = 0.54) and pulpotomies (P = 1) were NSS | |
LA-IANB (n = 36 C/T) | ~ 1.6 mL of 2% lidocaine, 1:80,000 epinephrine (Lignospan) was administered | ||||||||
Split-mouth | 6–12 (10.21 ± 1.4) M:39.3%- F: 61.7% | Cooperative enough to follow the instructor’s directions + histories of compliance at previous clinic visits/ Y | Class I amalgam restorations | EDA (n = 28 C) | (3 M Dental Electronic Anesthesia System 8670, 3 M Dental Products, St Paul, Minn) | Mandibular second primary molars and maxillary and mandibular first permanent molars/NM | Color scale/ SEM scale | The differences between LA and EDA regarding subjective and objective pain were NSS (P > 0.05) | |
LA (n = 28 C) | Conventional LA using 1.2 mL or 2/3 a cartridge of 2% lidocaine with 1:80,000 Epinephrine (Weimer Pharma GmbH, Rastatt, Germany) with 5-min waiting time | ||||||||
Split-mouth | 3–9 M: 47%- F: 53% | Cooperative at the initial visit/ Y | Class I and II amalgam restorations, SSC, formocresol pulpotomies, Ext | LA-infiltration (n = 152 T) | Mandibular infiltration was administered using 1.7 ml of lidocaine HCl 2% with epinephrine 1:100,000 (Xylestesin Forte, Espe Seefeld/Oberbay, Germany) in the mucobuccal fold between the roots of the first and second primary molars and in the mesial and distal papillae, with a 5-min waiting period | Mandibular primary molars/ NM | Presence or absence of pain based on sounds, and motor and ocular changes indicating pain (hand and body tension, eye movements indicating pain, verbal complaints, tears, and hand and body movements) | The difference between the two techniques was NSS | |
LA-IANB (n = 152 T) | Mandibular block was administered using the conventional technique and 1.7 ml of the anesthetic solution in addition to long buccal nerve injection | ||||||||
Split-mouth | 6–12 NM | Cooperative/ NM | Preventive resin restorations | EDA (n = 27 C) | TENS (Spectrum Max-SD®, Medical Designs, Westerville, OH; setting: pulse rate: 110 Hz, a normal mode pulse width of 225 microseconds, amplitude level: 7–12 mA, waveform: asymmetrical, rectangular, biphasic pulse with a net zero D.C. component). Disposable electrode pads (Dentrode 37®, The Electrode Store, Yucca Valley, CA) were used with a 5-min waiting time | Primary (22.2%)/permanent (77.8%) molars/NM | Eland Color Scale | Differences in pain perception between EDA and LA regarding effectiveness in controlling pain perception were NSS (P > 0.05) | |
LA (n = 27 C) | Traditional/conventional LA (maxilla: infiltration + lingual soft tissue anesthesia; mandible: Long buccal, inferior alveolar and lingual nerve blocks) using 2% lidocaine with 1:100,000 epinephrine (Xylocaine®, Astra, Westborough, MA) with 5 min waiting time | ||||||||
Crossover/split-mouth | 8–14 (11 ± 16) M: 50%- F: 50% | NM/ NM | Sealant placement | EDA-9 kHz (n = NM) | Peripheral electrical stimulation, 9/12/15/20/25 kHz electrical stimulus (Electro-Dental Anesthesia, Hauser Laboratories Inc., Boulder, Colo.), setting: waveform: trains of symmetrical rectangular wave pulses, maximum amplitude: 30 mA), 3 min waiting time | Maxillary and mandibular first (80%) or second (20%) permanent molars/NM | VAS (self-report and objective), heart rate using pulse oximeter | The increase in the heart rate was significantly less during electrical stimulation compared with sham stimulation (P < 0.05). The differences in subjects’ or investigator’s VAS scores between electrical and sham stimulation as well as the effectiveness of electrical stimulation between the 5 frequencies were NSS | |
EDA-12 kHz (n = NM) | |||||||||
EDA-15 kHz (n = NM) | |||||||||
EDA-20 kHz (n = NM) | |||||||||
EDA-25 kHz (n = NM) | |||||||||
Placebo (n = NM) | The device was not functional |
Authors, year of publication, country | Trial design | Age (years), gender (%) | Initial child behaviour/ Previous dental experiences | Interventions for reduction of pain/discomfort | Tooth type /eruption status | Assessment tool(s) for Pain/discomfort | Effectiveness of interventions during rubber dam application/clamp placement | |
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Category (#n) | Descriptions | |||||||
Wambier et al., 2018, [32] Brazil | Split-mouth | 8–12 (10.8 ± 0.5), M: 48%- F: 52% | NM/NM | TA gel-Exp (n = 81 T/C) | Liposomal thermo-sensitive Anesthetic Gel composed of 5% lidocaine and prilocaine/applied ~ 2 mm beyond the gingival marginal for 2 min | Mandibular 6 s/fully erupted | Odds of having pain: positive/negative Pain intensity 1- Wong-Baker FACES scale (0–5) 2- a 11-point numerical scale | Pain experience was NSS (OR: 0.7, %95 CI = 0.3–1.8). Pain intensity was statistically different for both assessment scales (P = 0.023 for numerical scale, P = 0.013 for Wong-Baker FACES scale) |
Placebo (n = 81 T/C) | Placebo gel/ applied ~ 2 mm beyond the gingival marginal for 2 min | |||||||
Wambier et al., 2018, [32] Brazil | Split-mouth | 8–12 (10.4 ± 1.0), M: 52%-F: 48% | NM/ NM | TA gel-Exp (n = 82 T/C) | A light-cured anesthetic gel (Patent-BR 1020160077249) containing tetracaine hydrochloride (5%), inhibitor, monomers, photoinitiator, co-initiator, dye and inert load. The gel was applied ~ 2 mm beyond the gingival margin, left untouched for 15 s before light curing with an LED device (Radii-cal, 1,200 mW/cm2). The waiting time was 30 s | Mandibular 6 s/ fully erupted | Absolute risk of pain: yes/no Pain intensity: 1- Facial expression Wong-Baker scale (0–5) 2-FLACC scale (0–10) 3- 11-point numeric rating scale (0–10) | The experimental light-cured anesthetic gel reduced the risk and intensity of pain compared to the placebo gel (p < 0.001) |
Placebo (n = 82 T/C) | Manipulated similar to the experimental TA gel | |||||||
Parallel | 6–15/NM | Uncooperative children were excluded/NM | TA-com (n = 18) | 2% lidocaine HCl (20 mg/1 g cream) cream, rubbed for 1 min and wait for 3 min, excipients: preservative (benzalkonium chloride), flavoring (thymol, aromatic oils), and emollients (liquid paraffin) with no anesthetic or analgesic properties | NM/NM | A 100-mm VAS | Pain reduction was significantly greater in the TA group than in the placebo group (P < 0.005) | |
Placebo (n = 21) | Placebo cream (with an identical excipient composition—20 mg water was used in place of the lidocaine HCl), rubbed for 1 min and wait for 3 min | |||||||
Split-mouth (pilot study) | 7–12, M: 40%- F: 60% | Cooperative patients whose behavior was not a contraindication to sealant placement (without behavior problems)/NM | TA-Com (n = 45 C) | Oraqix gel (2.5% lidocaine, 2.5% prilocaine, Dentsply Pharmaceutical, York, Pa), applied around the entire gingival sulcus, ~ 1/4 carpule or 0.4 g was used (depressing the applicator paddle 5 times) with 2 min waiting time | 6 s/ NM | Modified FPS | The overall difference between the two TA agents in mean FPS ratings was NSS (P = 0.27). Oraqix was more effective in 9-to-12- year-old children (P = 0.04) | |
TA-Com (n = 45 C) | 20% benzocaine gel (Patterson Dental, Saint Paul, Minn), applied on the gingiva surrounding the entire tooth with a Q-tip applicator with 2 min waiting time | |||||||
Split-mouth | 6–12 M: 42%- F: 58% | Children with behavioral difficulties on prior dental visits were excluded/ most were cooperative/NM | TA-Com (n = 31) | 0.5 g of EMLA (2.5% lidocaine and 2.5% prilocaine) cream (Astra Pharmaceuticals)/ applied on attached gingiva for 5 min | Maxillary (65%) and mandibular (35%) 6 s /completely or partially erupted | FPS | The mean FPS score for EMLA was significantly lower than that for non-EMLA (P < .001) | |
Placebo (n = 31) | 0.5 g of Vaseline/applied for 5 min on gingiva | |||||||
Split-mouth | 6.4–17.4 (11.3 ± 3.5) M: 58%- F: 42% | Cooperative (based on dental progress notes)/ NM | TA-Com (n = 37 T/28 C) | Mucosal adhesive patch (20% lidocaine) contained 46.1 mg of lidocaine in a bioadhesive matrix (DentiPatch), half of the patch was applied ~ 1 mm below the facial/lingual gingiva for 5 min | Maxillary or mandibular first and second premolars and permanent molars/ NM | VAS (0–100) | The differences in VAS/pain scores were NSS (P > .18) | |
TA-Com (n = 37 T/28 C) | Hurricaine Dry Handle Swab contained 0.25 mg of 20% benzocaine, 1 swab was applied to both the facial and lingual gingiva in equal amounts by alternating for 1 min |