Clinical trial NCT04353999: The Effect of Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation
Official title: The Effect of Diode Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation in the Esthetic Zone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Healing
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft.

Detailed description: The study was designed as randomized, controlled, clinical trial. patients who were undergoing tooth extraction and socket preservation were divided into two groups: Group I:980 nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of the socket

All patients were clinically and radiographically evaluated at the baseline and on the second , third and fourth weeks postoperatively.Then recalled after 4 months for the final radiographic examination.

Eligibility criteria: Inclusion Criteria:

1. The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
2. Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
3. Adult patients (aged 18-50 years).
4. A good standard of oral hygiene, as determined by the registration of an O'Leary Plaque Index of less than or equal to 10% after phase I therapy.

Exclusion Criteria:

1. The presence of any systemic disease that could complicate bone and soft tissue healing of the grafted socket.
2. The presence of any local factor that may interfere with extraction as tooth ankylosis.
3. Smoking.
4. The presence of bone dehiscence and fenestrations of the post-extractive alveolus (Type II and III sockets).
5. Subjects who had undergone radiation therapy.
6. Patients who had been subjected to or who were under bisphosphonate therapy.

Primary outcomes:
measure: Soft tissue healing (the changes in the soft tissue color throughout the first month)
timeFrame: at 2nd, 3rd and 4th week
Secondary outcomes:
measure: soft tissue thickness in millimeters.
timeFrame: 4 months
measure: Bone width and height measured in millimeters
timeFrame: 4 months
measure: pain score on the visual analogue scale (VAS)
timeFrame: 1 week
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of dentistry,Alexandria University
Study officials:
affiliation: Alexandria University
name: Ahmed A kamal, BDs
role: PRINCIPAL_INVESTIGATOR
References:
citation: Landry R, Turnbell R, Howley T. Effectiveness of benzydamyne HCl in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988;10:105-118.
citation: Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.
citation: Johnson K. A study of the dimensional changes occurring in the maxilla following tooth extraction. Aust Dent J. 1969 Aug;14(4):241-4. doi: 10.1111/j.1834-7819.1969.tb06001.x. No abstract available.
citation: Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.